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Integrated Care for Opioid Use Disorder and HIV (IMPACT Trial)

N/A
Waitlist Available
Led By Frederick Altice, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 6 months up to 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the outcomes of 1,350 people who inject drugs receiving methadone maintenance treatment at specialized clinics with those receiving treatment at primary care clinics. The trial will use a stratified, phase-in, cluster-controlled design over 24 months, and will examine the contribution of client, clinician and organizational factors that contribute to the composite primary outcome and individual secondary outcomes. A cost-effectiveness analysis will be conducted to compare the integrated HIV/MMT primary care model with the specialized MMT clinic model.

Who is the study for?
This trial is for people who inject drugs (PWID), are interested in methadone maintenance treatment (MMT), and meet the criteria for Opioid Dependence according to DSM-V. Participants must be willing to give consent.
What is being tested?
The study tests integrating HIV services with addiction treatment in primary care clinics versus specialty addiction clinics. It involves a randomized controlled design, comparing health outcomes and quality of life over 24 months among 1,350 PWIDs across different settings.
What are the potential side effects?
Since this trial focuses on service integration rather than a specific medical intervention, side effects are not the main concern; however, typical risks associated with MMT may include nausea, drowsiness, or mood changes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 6 months up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 months up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Average percentage of recommended Quality Health Indicator services accessed by participants to assess efficacy
Secondary study objectives
Average percentage of recommended HIV Quality Health Indicator services accessed to assess efficacy
Average percentage of recommended MMT Quality Health Indicator services accessed to assess efficacy
Average percentage of recommended TB Quality Health Indicator services accessed to assess efficacy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: ECHO-IC/QI-enhanced primary care clinicExperimental Treatment1 Intervention
Group II: Specialty Addiction ClinicActive Control1 Intervention
Group III: ECHO-IC/QI-enhanced primary care clinic with Pay for PerformanceActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,912 Previous Clinical Trials
3,038,014 Total Patients Enrolled
Ukrainian Institute on Public Health PolicyOTHER
6 Previous Clinical Trials
3,121 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,566 Previous Clinical Trials
3,256,689 Total Patients Enrolled

Media Library

Integration of HIV and PWID services Clinical Trial Eligibility Overview. Trial Name: NCT04927091 — N/A
Opioid Use Disorder Research Study Groups: ECHO-IC/QI-enhanced primary care clinic, Specialty Addiction Clinic, ECHO-IC/QI-enhanced primary care clinic with Pay for Performance
Opioid Use Disorder Clinical Trial 2023: Integration of HIV and PWID services Highlights & Side Effects. Trial Name: NCT04927091 — N/A
Integration of HIV and PWID services 2023 Treatment Timeline for Medical Study. Trial Name: NCT04927091 — N/A
~173 spots leftby Oct 2025
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